The Effect of Virtual Reality Glasses Pain, Anxiety and Satisfaction Level in Intrauterine Device Application'

NCT ID: NCT05655052

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-06-30

Brief Summary

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The aim of this study is to examine the effects of virtual reality glasses and distraction cards, which are cognitive behavioral techniques, on women's pain, anxiety and satisfaction levels. It is aimed to reduce your anxiety level, reduce pain level and increase feelings of satisfaction by showing you a nature video with Virtual Reality Glasses or showing distraction cards so that you can spend this process more comfortably while IUD is being applied. The following questions are expected to be answered in this research: When virtual reality glasses and distraction cards are applied during the IUD procedure; (1) Does it affect the woman's pain level? (2) Does it affect the woman's anxiety level? (3) does it have an effect on women's satisfaction? In addition, it is aimed to reveal the effectiveness of virtual reality glasses and distraction cards in the IUD application process, which is one of the modern family planning methods in midwifery applications, and to bring a non-invasive and cost-effective option into practice.

Detailed Description

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The proportion of women who want to use Family Planning in the world in the last two decades has reached approximately 1.1 billion and has shown a significant increase . Despite this increasing demand, it is seen that there has been a slow increase of 3.2 in the ratio of family planning (FP) needs met by modern contraceptive methods for women of reproductive age in the last ten years. The reasons for this slow increase include limited access to modern contraceptive methods, women's prejudice about some methods, and low quality of available services . In addition, WHO reported that almost half of pregnancies in developing countries between 2015 and 2019 were unwanted pregnancies , and recommended effective FP counseling and the use of more modern contraceptive methods to prevent this . In Turkey, the Ministry of Health provides individuals with free access to modern FP methods. Despite this, according to 2018 data of the Turkey Demographic and Health Survey (TNSA), it has been reported that 49% use modern methods in the use of FP method, and the Intrauterine Device (IUD) is among the most effective modern methods with a rate of 14% . Among the factors affecting the use of the IUD; women's perception of pain during the application and the fact that it can be applied in certain centers .

In addition, it has been reported in the literature that women perceive pain during IUD application. In these studies, pain; especially used in the stages of IUD application; It is reported that it is detected during tenaculum insertion, measurement with a hysterometer, and finally during IUD insertion. For this reason, there is a need for applications to reduce the pain associated with the IUD application, which is the modern FP method of women. Again, it is assumed that women will experience anxiety before the IUD application as in other medical procedures . It is seen in the literature that there are studies to alleviate the perceived pain in IUD application . In addition, it is expected that the applications made to women for the symptoms such as pain and anxiety related to the applications in the field of health will increase their satisfaction . In this context, there are studies in the literature showing that virtual reality glasses and distraction cards, which are cognitive behavioral techniques, are used during medical procedures, reducing the perception of pain and reducing the level of anxiety. . Although virtual reality glasses are a technological device, they have been widely used in the medical field in hospitals. Virtual reality glasses to be used in the research are not a medical device. This device is a technological glasses that works with compatible smartphones. The applications to be made with this device are within the framework of midwifery care applications and are not a treatment method, mediator or treatment option for any disease and do not have any harmful effects. Again, the cards with optical illusion figures on the distraction cards enable women to focus and reduce pain and anxiety.

No study has been found in the literature examining the effects of virtual reality glasses and distraction techniques on pain, anxiety and satisfaction levels in IUD application. However, in line with the results of the study, it is thought that the IUD procedure will have a positive effect on reducing the perceived pain and anxiety of women and increase satisfaction.

Conditions

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Virtual Reality Pain Anxiety Distraction Cards

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

: A randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers
According to the AP Polyclinic admission sequence number and from the list determined by randomization (determined from the www.randomizer.org site), which group it is in will be determined. Study and control group assignments will be made.

It will be applied by the health personnel working in the Family Planning Counseling Polyclinic.

Study Groups

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working grup 1: Virtual Reality (VR) Group

From the preparation stage of the IUD until the IUD application process is completed, after the internet connection is provided with a smart phone for the image, by clicking on the youtube.com link, Relaxation (https://www.youtube.com/watch?v=H1iboKia3AQ) nature video will be provided and virtual reality glasses will be provided.

Virtual reality glasses to be used in the research are not a medical device. This device is a technological glasses that works with compatible smartphones. The practice of watching nature videos with VR during the IUD application with this device is within the framework of midwifery care practices and is not a treatment option for any treatment method, tool or disease. Although the video watched with VR has no effect on medical treatment and care within the framework of midwifery care, it does not have any harmful effects on women. The participant can withdraw from this study at any time without giving any reason.

Group Type EXPERIMENTAL

Virtual Reality (VR) Group

Intervention Type DEVICE

At the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study.

* An introductory information form will be filled in for women in all three groups.
* While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses.
* Distraction Cards will be shown while the Intervention Group 2 IUD is being administered.
* The Control Group will be given routine IUD application and care.

Working Group 2: Distraction Cards Implementation Group

From the preparation stage of the IUD procedure to the completion of the IUD application process, distraction cards containing five optical illusion figures, one of the distraction techniques, will be shown to the women by the researcher . Distraction cards consist of picture cards with various hidden pictures and patterns. These hidden pictures and patterns are such that individuals can only see when they look carefully. During the process, the women will focus on the cards and be distracted by asking what they see on the cards by communicating face-to-face with the researcher women about the pictures and shapes they see on the cards. Thus, it is thought that the cards with optical figures on the distraction cards will enable women to focus and reduce pain and anxiety. Display of cards will take approximately 3-5 minutes

Group Type EXPERIMENTAL

Group using distraction cards

Intervention Type DEVICE

At the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study.

* An introductory information form will be filled in for women in all three groups.
* While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses.
* Distraction Cards will be shown while the Intervention Group 2 IUD is being administered.
* The Control Group will be given routine IUD application and care.

Control Group

Unlike the study group, women included in the control group will not only be shown video watching applications with virtual glasses and distraction cards. The maintenance and applications in the routine IUD application will be done exactly.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality (VR) Group

At the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study.

* An introductory information form will be filled in for women in all three groups.
* While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses.
* Distraction Cards will be shown while the Intervention Group 2 IUD is being administered.
* The Control Group will be given routine IUD application and care.

Intervention Type DEVICE

Group using distraction cards

At the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study.

* An introductory information form will be filled in for women in all three groups.
* While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses.
* Distraction Cards will be shown while the Intervention Group 2 IUD is being administered.
* The Control Group will be given routine IUD application and care.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* between the ages of 18-45,
* IUD applied,

Exclusion Criteria

* Having visual and auditory disabilities,
* Use of misoprostol during the procedure,
* Pre-procedure pain medication use,
* Pre-procedure anxiety medication use.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mine Gokduman Keles

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mine Gokduman Keles

Midwifery

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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TurkishMoHKahramanmarasPH

Kahramanmaraş, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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mine gökduman keleş

Role: CONTACT

05055624560

Eylem Toker

Role: CONTACT

Facility Contacts

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mine KELEŞ

Role: primary

5055624560

References

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Grimes DA, Lopez LM, Manion C, Schulz KF. Cochrane systematic reviews of IUD trials: lessons learned. Contraception. 2007 Jun;75(6 Suppl):S55-9. doi: 10.1016/j.contraception.2006.12.004. Epub 2007 Feb 16.

Reference Type BACKGROUND
PMID: 17531618 (View on PubMed)

Dina B, Peipert LJ, Zhao Q, Peipert JF. Anticipated pain as a predictor of discomfort with intrauterine device placement. Am J Obstet Gynecol. 2018 Feb;218(2):236.e1-236.e9. doi: 10.1016/j.ajog.2017.10.017. Epub 2017 Nov 8.

Reference Type BACKGROUND
PMID: 29079143 (View on PubMed)

Gemzell-Danielsson K, Jensen JT, Monteiro I, Peers T, Rodriguez M, Di Spiezio Sardo A, Bahamondes L. Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: An updated review. Acta Obstet Gynecol Scand. 2019 Dec;98(12):1500-1513. doi: 10.1111/aogs.13662. Epub 2019 Jun 27.

Reference Type BACKGROUND
PMID: 31112295 (View on PubMed)

Akdemir Y, Karadeniz M. The relationship between pain at IUD insertion and negative perceptions, anxiety and previous mode of delivery. Eur J Contracept Reprod Health Care. 2019 Jun;24(3):240-245. doi: 10.1080/13625187.2019.1610872. Epub 2019 May 16.

Reference Type RESULT
PMID: 31094575 (View on PubMed)

Hylton J, Milton S, Sima AP, Karjane NW. Cold Compress for Intrauterine Device Insertional Pain: A Randomized Control Trial. Womens Health Rep (New Rochelle). 2020 Aug 4;1(1):227-231. doi: 10.1089/whr.2020.0056. eCollection 2020.

Reference Type RESULT
PMID: 33786484 (View on PubMed)

Related Links

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https://www.who.int/news-room/fact-sheets/detail/family-planning-contraception

Home/Newsroom/Fact sheets/Detail/Family planning/contraception method

https://www.who.int/news/item/23-07-2020-new-estimates-show-worldwide-fall-in-unintended-pregnancies-since-1990-1994

WHO. New estimates show worldwide fall in unintended pregnancies since 1990-1994. 2020.

https://www.who.int/news/item/25-10-2019-high-rates-of-unintended-pregnancies-linked-to-gaps-in-family-planning-services-new-who-study

High rates of unintended pregnancies linked to gaps in family planning services: New WHO study

http://www.sck.gov.tr/wp-content/uploads/2020/08/TNSA2018_ana_Rapor.pdf

TNSA. Türkiye Nüfus ve Sağlık Araştırması 2018 Ne Söylüyor? 2018

Other Identifiers

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TurkishMoHKahramanmaras

Identifier Type: -

Identifier Source: org_study_id

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